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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033380
Receipt No. R000038059
Scientific Title Study of the relationship between oral function and cognitive decline in elderly people
Date of disclosure of the study information 2018/07/13
Last modified on 2019/07/14

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Basic information
Public title Study of the relationship between oral function and cognitive decline in elderly people
Acronym Study of the relationship between oral function and cognitive decline
Scientific Title Study of the relationship between oral function and cognitive decline in elderly people
Scientific Title:Acronym Study of the relationship between oral function and cognitive decline
Region
Japan

Condition
Condition Elderly person including mild cognitive impairment (MCI) individual
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of the change of oral function on the cognitive decline in elderly people including mild cognitive impairment(MCI) individual

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of MCI biomarkers during 2 year
Key secondary outcomes oral function, oral state

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) the patients who participated in research theme "Examination of relationship between oral function and cognitive decline in mild cognitive impairment elderly people with mild cognitive impairment"(Fukuoka Gakuen permission number No. 329)
(2) written informed consent provided for study participation
(3)the outpatient of Geriatric Dentistry in Fukuoka Dental College Hospital
(4) 65 years-old <=
(5) normal cognitive function and MCI
Key exclusion criteria (1) patient with dementia
(2) others whom the principal investigator decides to exclude
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Mizutani
Organization Kyushu University
Division name Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Diagnostic and Surgical Sciences Faculty of Dental Science
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL 092-642-6485
Email mizutani@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Mizutani
Organization Kyushu University
Division name Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Di
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL 092-642-6485
Homepage URL
Email mizutani@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukuoka dental college
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 04 Day
Date of IRB
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 07 Month 04 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study
study design: cohort study

Management information
Registered date
2018 Year 07 Month 13 Day
Last modified on
2019 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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